Tandem Diabetes Care issued an urgent medical device correction to upgrade the software of its Tandem Mobi insulin pumps that ...

MPMN recently spoke with Kevin Fu, software expert and associate professor of computer science at the University of Massachusetts Amherst, about the current risks associated with medical device ...

In medical-device software, an update isn’t just a new feature — it can directly affect patient safety. Every code change in a surgical-laser system must be fully traceable to its verification and ...

Software-based medical devices are integral to healthcare. To enter the marketplace, a company must successfully navigate and comply with applicable national and international regulatory requirements.

“Don’t fear the Reaper,” the rock band Blue Öyster Cult famously advised. For many digital health companies, the Food and Drug Administration’s recently revised guidances affecting the classification ...

Software updates can be useful, but over time, many of us develop a habit of ignoring them altogether for the less-used devices or ones that we don't actively engage with. When things appear to be ...